Background to clinical data publication policy

The European Medicines Agency developed its policy on the publication of clinical data for human medicines, taking account of the views and concerns of a broad range of stakeholders and European bodies. The policy complements other policies and mechanisms to ensure transparency.

The Agency is committed to continuously extending its approach to transparency. A key goal in this process is the publication of clinical data for medicines once the decision-making process on an application for a European Union (EU)-wide marketing authorisation is complete. Clinical data are defined as clinical reports and individual patient data (IPD).

EMA will implement the policy in two phases.

Phase 1 concerns the publication of clinical reports submitted to the Agency. It entered into force on 1 January 2015.

Phase 2 concerns the publication of IPD. EMA will implement this phase at a later stage.

The Agency embarked on this process because it believes that the release of data will cement trust and confidence in the regulatory system, allowing the public to better understand the Agency’s regulatory decision-making.

Following the event, the Agency issued a call for nominations to join advisory groups to inform it on five topics. The groups met between January and April 2013, with meetings taking place via teleconference. For more information on the topics and the composition of the advisory groups see

The Agency reviewed and analysed the comments based on a set of key principles agreed by the Agency’s Management Board on 12 December 2013. These included:

a stepwise approach for implementation with, as a first step, preparation for the publication of clinical study reports redacted as appropriate;

development of a methodology for de-identification of patients;

definition of a standard format for the submission of data.

The principles also included the introduction of preliminary steps prior to data access designed to address the risk of possible unfair commercial use of data, while ensuring proactive and non-selective access (‘use control’ not ‘access control’).

Targeted stakeholder consultation

The policy was discussed at the March 2014 Management Board meeting and three meetings or teleconferences were held in May 2014 with patient and consumer organisations and healthcare professional organisations, pharmaceutical industry associations, including small and medium sized enterprises, and representatives from academia, research bodies, and medical journals.

Stakeholders were consulted on the principles set for possible redaction of the clinical study reports to be published, and the technical measures to make the data available under the policy, including the terms of use:

In 2015 EMA consulted stakeholders extensively, as well as the European Ombudsman and the European Data Protection Supervisor.

Reactive release of documents

Since 2010 the Agency has been releasing clinical-trial reports on request, under its access-to-documents policy.

The access to documents policy enables third parties to request the release of documents held by the Agency, including documents submitted as part of marketing-authorisation applications. For more information, see Access to documents.